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Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension

C

Centre Epaule Coude CEPCO

Status

Enrolling

Conditions

Shoulder Dislocation
Shoulder Instability

Treatments

Other: Rehabilitation physiotherapy
Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05767957
2021-01912

Details and patient eligibility

About

Randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. Comparison of 2 physiotherapy techniques in the context of shoulder instability.

Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone.

Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.

Full description

Traumatic anterior instability of the shoulder is one of the most frequent lesions of the shoulder, the majority of cases of which occur in adolescents, with a risk of recurrence close to 90% if it occurs before the age of 20 years. It can be treated conservatively or surgically. Stabilizing surgery of the glenohumeral joint offers satisfactory results for people suffering from shoulder instability. Like subjects treated conservatively, patients undergoing stabilizing surgery remain apprehensive after the operation in 2 to 51% of cases. Currently, no rehabilitation program has demonstrated superior effectiveness, during instability treated conservatively or during postoperative rehabilitation. Recent studies have shown that cortical reorganization takes place, especially in areas of fear and anxiety. Faced with the need to develop physiotherapeutic management in post-traumatic unstable shoulder, this study aims to evaluate the contribution of cognitive-behavioral therapy, by including a neuropsychological axis in the rehabilitation of patients.

This study is randomized and controlled, multicenter, including 144 patients suffering from apprehension of the shoulder, divided into two treatment groups. Both groups will receive a conventional physiotherapy protocol including individual sessions and home exercises. The physiotherapists in the intervention group will also have received training in the use of techniques from Cognitive-Behavioral Therapies. Data will be collected before the introduction of physiotherapy, after 6, 12, 24 and 52 weeks of treatment. In the event of surgery, the data will also be collected preoperatively. The primary outcome is apprehension measured by the Rowe score. The secondary outcomes are apprehension measured by the apprehension and relocation tests, and the Tampa Scale for Kinesiophobia, as well as shoulder function, measured by the Simple Shoulder Test and the Subjective Shoulder Value.

Enrollment

144 estimated patients

Sex

All

Ages

15 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • positive apprehension test;
  • traumatic anterior dislocation of the glenohumeral joint requiring or not surgical stabilization according to Bankart or Latarjet;
  • good oral and written comprehension of French;
  • age between 15 and 45 years old.

Exclusion criteria

  • associated tendon injury requiring surgical treatment;
  • fracture other than Bankart fracture;
  • multidirectional instability (MDI);
  • peripheral neurological lesion in the upper limb;
  • central neurological lesion;
  • diagnosed psychosis, depression or epilepsy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

144 participants in 2 patient groups

Control group
Active Comparator group
Treatment:
Other: Rehabilitation physiotherapy
Intervention group
Experimental group
Treatment:
Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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